510(k) K974630

72 HOUR USE TRACH CARE WITH MICROBAN by Ballard Medical Products — Product Code CAH

K974630 is an FDA 510(k) premarket notification submitted by Ballard Medical Products for the device "72 HOUR USE TRACH CARE WITH MICROBAN". The FDA issued a decision of Substantially Equivalent on March 11, 1998. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Ballard Medical Products has at least 10 other 510(k) clearances on record.